DUAC® Early Onset Efficacy Study in Japanese Subjects

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DUAC® (clindamycin phosphate 1.2 percent [%] + benzoyl peroxide 3%) is the registered product of GlaxoSmithKline. This study was conducted between 07 October 2015 and 17 February 2016 in which 349 participants were randomized.

Pre-assignment Details

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 finger tip unit (FTU) about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity equal to about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of ADA 0.1% gel with quantity equal to about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.

The assessor performed a count of IL (papules, pustules, nodular lesio...

Description

The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-inflammatory lesions were counted by diagnosis based on palpation of the investigator (or sub-investigator).

Time Frame

Baseline (Day 1) and Week 2

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Intent-to-Treat (ITT) population comprised of all randomized participants who received at least one application of study product. Only those participants with data available at the indicated time points were analyzed

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

2.Secondary Outcome

Title

Percent Change From Baseline in TLs to Weeks 1, 4, 8 and 12

Description

The assessor performed a count of IL (papules, pustules, nodular lesio...

Description

The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Time Frame

Baseline (Day 1) and Week 1, 4, 8, 12

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.

The assessor performed a count of IL (papules, pustules, nodular lesio...

Description

The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones). Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator).

Time Frame

Baseline (Day 1) and Week 1, 2, 4, 8, 12

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.

The assessor performed a count of IL (papules, pustules, nodular lesio...

Description

The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM. The Baseline value was the latest pre-dose assessment value.

Time Frame

Baseline (Day 1) and Week 1, 2, 4, 8, 12

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

5.Secondary Outcome

Title

Percentage of Participants With a Minimum of 2-grade Improvement in Investigator's Static Global Assessment (ISGA) Score From Baseline to Weeks 1, 2, 4, 8 and 12

Description

Responder was defined as participants with a minimum 2-grade improveme...

Description

Responder was defined as participants with a minimum 2-grade improvement in ISGA score from Baseline. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 2-grade improvement in ISGA score from Baseline by total number of participants value multiplied by 100.

Time Frame

Week 1, 2, 4, 8, 12

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

ITT population.

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.

Overall Number of Participants Analyzed

172

177

Measure Type: Number

Unit of Measure: Percentage of participants

Week 1

2

0

Week 2

6

3

Week 4

12

8

Week 8

22

12

Week 12

37

27

Statistical Analysis 1

Statistical Analysis 1

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.047

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

2.3

Confidence Interval

(2-Sided) 95%

0.1
to 4.6

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1.The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 2

Statistical Analysis 2

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.185

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

3.0

Confidence Interval

(2-Sided) 95%

-1.3
to 7.3

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 3

Statistical Analysis 3

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.251

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

3.7

Confidence Interval

(2-Sided) 95%

-2.5
to 9.9

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 4

Statistical Analysis 4

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.006

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

10.2

Confidence Interval

(2-Sided) 95%

2.4
to 18.0

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 5

Statistical Analysis 5

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.022

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

10.7

Confidence Interval

(2-Sided) 95%

0.9
to 20.4

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

6.Secondary Outcome

Title

Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12

Description

Responder was defined as participant with ISGA score of 0 or 1. ISGA s...

Description

Responder was defined as participant with ISGA score of 0 or 1. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 0-1 ISGA score post Baseline by total number of participants value multiplied by 100.

Time Frame

Week 1, 2, 4, 8 and 12

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

ITT population.

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.

Overall Number of Participants Analyzed

172

177

Measure Type: Number

Unit of Measure: Percentage of participants

Week 1

2

1

Week 2

6

5

Week 4

13

6

Week 8

20

12

Week 12

41

29

Statistical Analysis 1

Statistical Analysis 1

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.129

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

1.8

Confidence Interval

(2-Sided) 95%

-0.7
to 4.3

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 2

Statistical Analysis 2

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.612

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

1.3

Confidence Interval

(2-Sided) 95%

-3.4
to 5.9

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 3

Statistical Analysis 3

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.016

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

7.1

Confidence Interval

(2-Sided) 95%

1.1
to 13.2

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 4

Statistical Analysis 4

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.034

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

7.9

Confidence Interval

(2-Sided) 95%

0.3
to 15.5

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 5

Statistical Analysis 5

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.018

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

11.3

Confidence Interval

(2-Sided) 95%

1.4
to 21.3

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

7.Secondary Outcome

Title

Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12

Description

Responder was defined as participants with at least a 50% reduction in...

Description

Responder was defined as participants with at least a 50% reduction in TLs, ILs and non-ILs. Data for number of participants is reported. Percentage of participants was calculated by dividing number of responders by total number of participants value multiplied by 100.

Time Frame

Week 1, 2, 4, 8 and 12

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.

Overall Number of Participants Analyzed

172

177

Measure Type: Number

Unit of Measure: Percentage of participants

Week 1 TLs

Number Analyzed

172 participants

176 participants

22

18

Week 2 TLs

Number Analyzed

172 participants

177 participants

47

42

Week 4 TLs

Number Analyzed

172 participants

177 participants

67

60

Week 8 TLs

Number Analyzed

172 participants

177 participants

81

81

Week 12 TLs

Number Analyzed

172 participants

177 participants

88

86

Week 1 ILs

Number Analyzed

172 participants

176 participants

51

42

Week 2 ILs

Number Analyzed

172 participants

177 participants

77

66

Week 4 ILs

Number Analyzed

172 participants

177 participants

85

76

Week 8 ILs

Number Analyzed

172 participants

177 participants

87

84

Week 12 ILs

Number Analyzed

172 participants

177 participants

92

89

Week 1 non-ILs

Number Analyzed

172 participants

176 participants

14

16

Week 2 non-ILs

Number Analyzed

172 participants

177 participants

37

34

Week 4 non-ILs

Number Analyzed

172 participants

177 participants

58

54

Week 8 non-ILs

Number Analyzed

172 participants

177 participants

73

73

Week 12 non-ILs

Number Analyzed

172 participants

177 participants

83

80

Statistical Analysis 1

Statistical Analysis 1

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.379

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

3.9

Confidence Interval

(2-Sided) 95%

-4.5
to 12.3

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 2

Statistical Analysis 2

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.409

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

4.7

Confidence Interval

(2-Sided) 95%

-5.7
to 15.1

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 3

Statistical Analysis 3

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.180

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

7.0

Confidence Interval

(2-Sided) 95%

-3.1
to 17.0

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 4

Statistical Analysis 4

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.810

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

-0.5

Confidence Interval

(2-Sided) 95%

-8.8
to 7.7

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 5

Statistical Analysis 5

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.648

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

1.9

Confidence Interval

(2-Sided) 95%

-5.2
to 9.0

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 6

Statistical Analysis 6

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.048

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

9.1

Confidence Interval

(2-Sided) 95%

-1.3
to 19.6

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 7

Statistical Analysis 7

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.016

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

11.2

Confidence Interval

(2-Sided) 95%

1.8
to 20.6

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 8

Statistical Analysis 8

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.044

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

8.6

Confidence Interval

(2-Sided) 95%

0.4
to 16.9

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 9

Statistical Analysis 9

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.345

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

3.6

Confidence Interval

(2-Sided) 95%

-3.8
to 11.0

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 10

Statistical Analysis 10

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.424

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

2.6

Confidence Interval

(2-Sided) 95%

-3.5
to 8.7

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 11

Statistical Analysis 11

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.527

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

-2.0

Confidence Interval

(2-Sided) 95%

-9.4
to 5.5

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 12

Statistical Analysis 12

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.584

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

3.3

Confidence Interval

(2-Sided) 95%

-6.7
to 13.4

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 13

Statistical Analysis 13

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.519

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

3.9

Confidence Interval

(2-Sided) 95%

-6.5
to 14.3

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 14

Statistical Analysis 14

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.766

Comments

The P-values are based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Difference in percentage

Estimated Value

-0.8

Confidence Interval

(2-Sided) 95%

-10.1
to 8.5

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 15

Statistical Analysis 15

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.666

Comments

The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.

Method

Cochran-Mantel-Haenszel

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Odds Ratio (OR)

Estimated Value

2.3

Confidence Interval

(2-Sided) 95%

-5.8
to 10.5

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

8.Secondary Outcome

Title

Number of Participants With Treatment Adherence Rate at Weeks 1, 2, 4, 8 and 12

The investigator (or sub-investigator), the product storage manager, or the blinded coordinator dispensed a study compliance log to record participant's compliance with investigational product application from Baseline to the end of study treatment. The product storage manager or the blinded coordinator evaluated the participant's compliance with study treatment, using the study compliance log at each visit, and recorded the compliance data in the eCRF.

Time Frame

Week 1, 2, 4, 8 and 12

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

ITT population.

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.

Overall Number of Participants Analyzed

172

177

Measure Type: Number

Unit of Measure: Participants

week 1

143

131

week 2

125

115

week 4

110

85

week 8

89

72

week 12

88

63

9.Secondary Outcome

Title

Number of Participants Who Continued Treatment at Weeks 1, 2, 4, 8 and 12

Description

Number of participants who continued the treatment till Week 12 was me...

Description

Number of participants who continued the treatment till Week 12 was measured. Overall data for participants who have not missed any dose during the treatment period has been reported.

Time Frame

Up to Week 12

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

ITT population.

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.

Overall Number of Participants Analyzed

172

177

Measure Type: Number

Unit of Measure: Participants

63

59

10.Secondary Outcome

Title

Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12

Description

Participants had to rate each question on a 5-point scale of 0 to 4 (4...

Description

Participants had to rate each question on a 5-point scale of 0 to 4 (4: yes, very easy to use, 3: yes, easy, 2: slightly easy, 1: slightly difficult, 0: No) where larger score indicates more preferable participant's feeling. There were 5 questions in the questionnaire: ease of application, comfort, satisfaction with treatment (ST), comparison with prior therapies (CPT) and willingness to continue using the product (WCP).

Time Frame

Week 1, 2, 4, 8 and 12

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.

Overall Number of Participants Analyzed

172

177

Measure Type: Count of Participants

Unit of Measure: Participants

Week 1: Ease of application, Score 4

Number Analyzed

172 participants

176 participants

131

76.2%

95

54.0%

Week 1: Ease of application, Score 3

Number Analyzed

172 participants

176 participants

38

22.1%

66

37.5%

Week 1: Ease of application, Score 2

Number Analyzed

172 participants

176 participants

2

1.2%

13

7.4%

Week 1: Ease of application, Score 1

Number Analyzed

172 participants

176 participants

1

0.6%

2

1.1%

Week 2: Ease of application, Score 4

Number Analyzed

169 participants

176 participants

128

75.7%

83

47.2%

Week 2: Ease of application, Score 3

Number Analyzed

169 participants

176 participants

38

22.5%

75

42.6%

Week 2: Ease of application, Score 2

Number Analyzed

169 participants

176 participants

2

1.2%

17

9.7%

Week 2: Ease of application, Score 1

Number Analyzed

169 participants

176 participants

1

0.6%

1

0.6%

Week 4: Ease of application, Score 4

Number Analyzed

169 participants

174 participants

118

69.8%

85

48.9%

Week 4: Ease of application, Score 3

Number Analyzed

169 participants

174 participants

49

29.0%

70

40.2%

Week 4: Ease of application, Score 2

Number Analyzed

169 participants

174 participants

2

1.2%

18

10.3%

Week 4: Ease of application, Score 1

Number Analyzed

169 participants

174 participants

0

0.0%

1

0.6%

Week 8: Ease of application, Score 4

Number Analyzed

167 participants

172 participants

114

68.3%

90

52.3%

Week 8: Ease of application, Score 3

Number Analyzed

167 participants

172 participants

50

29.9%

60

34.9%

Week 8: Ease of application, Score 2

Number Analyzed

167 participants

172 participants

3

1.8%

19

11.0%

Week 8: Ease of application, Score 1

Number Analyzed

167 participants

172 participants

0

0.0%

3

1.7%

Week 12: Ease of application, Score 4

Number Analyzed

164 participants

169 participants

116

70.7%

81

47.9%

Week 12: Ease of application, Score 3

Number Analyzed

164 participants

169 participants

44

26.8%

68

40.2%

Week 12: Ease of application, Score 2

Number Analyzed

164 participants

169 participants

4

2.4%

18

10.7%

Week 12: Ease of application, Score 1

Number Analyzed

164 participants

169 participants

0

0.0%

2

1.2%

Week 1: Comfort, Score 4

Number Analyzed

172 participants

176 participants

37

21.5%

24

13.6%

Week 1: Comfort, Score 3

Number Analyzed

172 participants

176 participants

86

50.0%

69

39.2%

Week 1: Comfort, Score 2

Number Analyzed

172 participants

176 participants

37

21.5%

45

25.6%

Week 1: Comfort, Score 1

Number Analyzed

172 participants

176 participants

7

4.1%

32

18.2%

Week 1: Comfort, Score 0

Number Analyzed

172 participants

176 participants

5

2.9%

6

3.4%

Week 2: Comfort, Score 4

Number Analyzed

169 participants

176 participants

56

33.1%

35

19.9%

Week 2: Comfort, Score 3

Number Analyzed

169 participants

176 participants

70

41.4%

81

46.0%

Week 2: Comfort, Score 2

Number Analyzed

169 participants

176 participants

36

21.3%

42

23.9%

Week 2: Comfort, Score 1

Number Analyzed

169 participants

176 participants

6

3.6%

17

9.7%

Week 2: Comfort, Score 0

Number Analyzed

169 participants

176 participants

1

0.6%

1

0.6%

Week 4: Comfort, Score 4

Number Analyzed

169 participants

174 participants

72

42.6%

47

27.0%

Week 4: Comfort, Score 3

Number Analyzed

169 participants

174 participants

75

44.4%

80

46.0%

Week 4: Comfort, Score 2

Number Analyzed

169 participants

174 participants

17

10.1%

31

17.8%

Week 4: Comfort, Score 1

Number Analyzed

169 participants

174 participants

5

3.0%

15

8.6%

Week 4: Comfort, Score 0

Number Analyzed

169 participants

174 participants

0

0.0%

1

0.6%

Week 8: Comfort, Score 4

Number Analyzed

167 participants

172 participants

79

47.3%

53

30.8%

Week 8: Comfort, Score 3

Number Analyzed

167 participants

172 participants

69

41.3%

68

39.5%

Week 8: Comfort, Score 2

Number Analyzed

167 participants

172 participants

18

10.8%

36

20.9%

Week 8: Comfort, Score 1

Number Analyzed

167 participants

172 participants

1

0.6%

13

7.6%

Week 8: Comfort, Score 0

Number Analyzed

167 participants

172 participants

0

0.0%

2

1.2%

Week 12: Comfort, Score 4

Number Analyzed

164 participants

169 participants

84

51.2%

56

33.1%

Week 12: Comfort, Score 3

Number Analyzed

164 participants

169 participants

66

40.2%

73

43.2%

Week 12: Comfort, Score 2

Number Analyzed

164 participants

169 participants

13

7.9%

26

15.4%

Week 12: Comfort, Score 1

Number Analyzed

164 participants

169 participants

1

0.6%

13

7.7%

Week 12: Comfort, Score 0

Number Analyzed

164 participants

169 participants

0

0.0%

1

0.6%

Week 1: ST, Score 4

Number Analyzed

172 participants

176 participants

36

20.9%

21

11.9%

Week 1: ST, Score 3

Number Analyzed

172 participants

176 participants

79

45.9%

75

42.6%

Week 1: ST, Score 2

Number Analyzed

172 participants

176 participants

46

26.7%

49

27.8%

Week 1: ST, Score 1

Number Analyzed

172 participants

176 participants

11

6.4%

23

13.1%

Week 1: ST, Score 0

Number Analyzed

172 participants

176 participants

0

0.0%

8

4.5%

Week 2: ST, Score 4

Number Analyzed

169 participants

176 participants

58

34.3%

38

21.6%

Week 2: ST, Score 3

Number Analyzed

169 participants

176 participants

70

41.4%

81

46.0%

Week 2: ST, Score 2

Number Analyzed

169 participants

176 participants

37

21.9%

47

26.7%

Week 2: ST, Score 1

Number Analyzed

169 participants

176 participants

4

2.4%

7

4.0%

Week 2: ST, Score 0

Number Analyzed

169 participants

176 participants

0

0.0%

3

1.7%

Week 4: ST, Score 4

Number Analyzed

169 participants

174 participants

66

39.1%

44

25.3%

Week 4: ST, Score 3

Number Analyzed

169 participants

174 participants

72

42.6%

81

46.6%

Week 4: ST, Score 2

Number Analyzed

169 participants

174 participants

27

16.0%

40

23.0%

Week 4: ST, Score 1

Number Analyzed

169 participants

174 participants

4

2.4%

8

4.6%

Week 4: ST, Score 0

Number Analyzed

169 participants

174 participants

0

0.0%

1

0.6%

Week 8: ST, Score 4

Number Analyzed

167 participants

172 participants

78

46.7%

58

33.7%

Week 8: ST, Score 3

Number Analyzed

167 participants

172 participants

67

40.1%

72

41.9%

Week 8: ST, Score 2

Number Analyzed

167 participants

172 participants

17

10.2%

33

19.2%

Week 8: ST, Score 1

Number Analyzed

167 participants

172 participants

5

3.0%

6

3.5%

Week 8: ST, Score 0

Number Analyzed

167 participants

172 participants

0

0.0%

3

1.7%

Week 12: ST, Score 4

Number Analyzed

164 participants

169 participants

82

50.0%

63

37.3%

Week 12: ST, Score 3

Number Analyzed

164 participants

169 participants

61

37.2%

70

41.4%

Week 12: ST, Score 2

Number Analyzed

164 participants

169 participants

20

12.2%

29

17.2%

Week 12: ST, Score 1

Number Analyzed

164 participants

169 participants

1

0.6%

6

3.6%

Week 12: ST, Score 0

Number Analyzed

164 participants

169 participants

0

0.0%

1

0.6%

Week 1: CPT, Score 4

Number Analyzed

172 participants

176 participants

77

44.8%

53

30.1%

Week 1: CPT, Score 3

Number Analyzed

172 participants

176 participants

50

29.1%

45

25.6%

Week 1: CPT, Score 2

Number Analyzed

172 participants

176 participants

38

22.1%

61

34.7%

Week 1: CPT, Score 1

Number Analyzed

172 participants

176 participants

7

4.1%

11

6.3%

Week 1: CPT, Score 0

Number Analyzed

172 participants

176 participants

0

0.0%

6

3.4%

Week 2: CPT, Score 4,

Number Analyzed

169 participants

176 participants

90

53.3%

57

32.4%

Week 2: CPT, Score 3

Number Analyzed

169 participants

176 participants

51

30.2%

55

31.3%

Week 2: CPT, Score 2

Number Analyzed

169 participants

176 participants

25

14.8%

54

30.7%

Week 2: CPT, Score 1

Number Analyzed

169 participants

176 participants

2

1.2%

10

5.7%

Week 2: CPT, Score 0

Number Analyzed

169 participants

176 participants

1

0.6%

0

0.0%

Week 4: CPT, Score 4

Number Analyzed

169 participants

174 participants

100

59.2%

67

38.5%

Week 4: CPT, Score 3

Number Analyzed

169 participants

174 participants

47

27.8%

52

29.9%

Week 4: CPT, Score 2

Number Analyzed

169 participants

174 participants

18

10.7%

46

26.4%

Week 4: CPT, Score 1

Number Analyzed

169 participants

174 participants

4

2.4%

8

4.6%

Week 4: CPT, Score 0

Number Analyzed

169 participants

174 participants

0

0.0%

1

0.6%

Week 8: CPT, Score 4

Number Analyzed

167 participants

172 participants

109

65.3%

73

42.4%

Week 8: CPT, Score 3

Number Analyzed

167 participants

172 participants

38

22.8%

50

29.1%

Week 8: CPT, Score 2

Number Analyzed

167 participants

172 participants

19

11.4%

40

23.3%

Week 8: CPT, Score 1

Number Analyzed

167 participants

172 participants

1

0.6%

8

4.7%

Week 8: CPT, Score 0

Number Analyzed

167 participants

172 participants

0

0.0%

1

0.6%

Week 12: CPT, Score 4

Number Analyzed

164 participants

169 participants

112

68.3%

78

46.2%

Week 12: CPT, Score 3

Number Analyzed

164 participants

169 participants

42

25.6%

47

27.8%

Week 12: CPT, Score 2

Number Analyzed

164 participants

169 participants

8

4.9%

35

20.7%

Week 12: CPT, Score 1

Number Analyzed

164 participants

169 participants

2

1.2%

7

4.1%

Week 12: CPT, Score 0

Number Analyzed

164 participants

169 participants

0

0.0%

2

1.2%

Week 1: WCP, Score 4

Number Analyzed

172 participants

176 participants

64

37.2%

36

20.5%

Week 1: WCP, Score 3

Number Analyzed

172 participants

176 participants

79

45.9%

78

44.3%

Week 1: WCP, Score 2

Number Analyzed

172 participants

176 participants

25

14.5%

39

22.2%

Week 1: WCP, Score 1

Number Analyzed

172 participants

176 participants

4

2.3%

19

10.8%

Week 1: WCP, Score 0

Number Analyzed

172 participants

176 participants

0

0.0%

4

2.3%

Week 2: WCP, Score 4

Number Analyzed

169 participants

176 participants

75

44.4%

55

31.3%

Week 2: WCP, Score 3

Number Analyzed

169 participants

176 participants

72

42.6%

70

39.8%

Week 2: WCP, Score 2

Number Analyzed

169 participants

176 participants

19

11.2%

38

21.6%

Week 2: WCP, Score 1

Number Analyzed

169 participants

176 participants

3

1.8%

13

7.4%

Week 4: WCP, Score 4

Number Analyzed

169 participants

174 participants

88

52.1%

63

36.2%

Week 4: WCP, Score 3

Number Analyzed

169 participants

174 participants

63

37.3%

75

43.1%

Week 4: WCP, Score 2

Number Analyzed

169 participants

174 participants

15

8.9%

26

14.9%

Week 4: WCP, Score 1

Number Analyzed

169 participants

174 participants

3

1.8%

10

5.7%

Week 8: WCP, Score 4

Number Analyzed

167 participants

172 participants

90

53.9%

62

36.0%

Week 8: WCP, Score 3

Number Analyzed

167 participants

172 participants

59

35.3%

74

43.0%

Week 8: WCP, Score 2

Number Analyzed

167 participants

172 participants

15

9.0%

27

15.7%

Week 8: WCP, Score 1

Number Analyzed

167 participants

172 participants

3

1.8%

9

5.2%

Week 12: WCP, Score 4

Number Analyzed

164 participants

169 participants

94

57.3%

70

41.4%

Week 12: WCP, Score 3

Number Analyzed

164 participants

169 participants

56

34.1%

65

38.5%

Week 12: WCP, Score 2

Number Analyzed

164 participants

169 participants

12

7.3%

23

13.6%

Week 12: WCP, Score 1

Number Analyzed

164 participants

169 participants

1

0.6%

11

6.5%

Week 12: WCP, Score 0

Number Analyzed

164 participants

169 participants

1

0.6%

0

0.0%

11.Secondary Outcome

Title

Change From Baseline in Quality of Life (QoL) Score at Week 2, 4, 8 and 12

Description

QOL questionnaire was assessed using Skindex-16 with 16 questions in 3...

Description

QOL questionnaire was assessed using Skindex-16 with 16 questions in 3 multi-item scales: symptoms, emotions and functioning for the past week: skin condition-itching, burning or stinging, hurting, being irritated, persistence/reoccurrence of skin condition, worry about condition, appearance of skin, frustration about skin, embarrassment about skin, being annoyed about your skin, feeling depressed about skin, effects of your skin on your interactions with others, effects of your skin condition on your desire to be with people, skin condition making it hard to show affection, effects of your skin condition on your daily activities and skin condition making it hard to work or do what you enjoy. Data for adjusted mean has been reported. The Baseline value was the latest pre-dose assessment value. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Scores range from 0-never bothered to 100-always bothered.

Time Frame

Baseline(Day 1) and Week 2, 4, 8 and 12

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.

Overall Number of Participants Analyzed

172

177

Least Squares Mean (Standard Error)

Unit of Measure: Score on scale

Week 2

Number Analyzed

169 participants

176 participants

-0.71
(0.070)

-0.49
(0.068)

Week 4

Number Analyzed

169 participants

174 participants

-1.02
(0.069)

-0.80
(0.068)

Week 8

Number Analyzed

167 participants

172 participants

-1.14
(0.073)

-0.92
(0.071)

Week 12

Number Analyzed

164 participants

169 participants

-1.27
(0.073)

-1.10
(0.072)

Statistical Analysis 1

Statistical Analysis 1

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.017

Comments

[Not Specified]

Method

mixed model repeated measures analysis

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Mean Difference (Net)

Estimated Value

-0.22

Confidence Interval

(2-Sided) 95%

-0.40
to -0.04

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 2

Statistical Analysis 2

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.017

Comments

[Not Specified]

Method

mixed model repeated measures analysis

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Mean Difference (Net)

Estimated Value

-0.22

Confidence Interval

(2-Sided) 95%

-0.40
to -0.04

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 3

Statistical Analysis 3

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.024

Comments

[Not Specified]

Method

mixed model repeated measures analysis

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Mean Difference (Net)

Estimated Value

-0.22

Confidence Interval

(2-Sided) 95%

-0.41
to -0.03

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 4

Statistical Analysis 4

Statistical Analysis Overview

Comparison Group Selection

DUAC, ADA 0.1% +CLDM 1%

Comments

[Not Specified]

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.080

Comments

[Not Specified]

Method

mixed model repeated measures analysis

Comments

[Not Specified]

Method of Estimation

Estimation Parameter

Mean Difference (Net)

Estimated Value

-0.17

Confidence Interval

(2-Sided) 95%

-0.36
to 0.02

Estimation Comments

Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

12.Secondary Outcome

Title

Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

An AE was defined as any untoward medical occurrence that occurred dur...

Description

An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate. For liver injury and impaired liver function, alanine aminotransferase greater than or equal to (>=)3 times upper limit of normal (ULN) and total bilirubin >=2xULN (less than [>] 35% direct) was defined.

Time Frame

Up to Week 12

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

ITT population.

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.

Overall Number of Participants Analyzed

172

177

Measure Type: Count of Participants

Unit of Measure: Participants

Any AE

53

30.8%

100

56.5%

Any SAE

1

0.6%

0

0.0%

13.Secondary Outcome

Title

Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.

Overall Number of Participants Analyzed

172

177

Mean (Standard Deviation)

Unit of Measure: Score on scale

Erythema Week 1

Number Analyzed

170 participants

175 participants

0.0
(0.61)

0.3
(0.72)

Erythema Week 2

Number Analyzed

169 participants

175 participants

0.0
(0.68)

0.0
(0.70)

Erythema Week 4

Number Analyzed

169 participants

174 participants

-0.1
(0.57)

-0.1
(0.64)

Erythema Week 8

Number Analyzed

165 participants

171 participants

-0.2
(0.68)

-0.2
(0.69)

Erythema Week 12

Number Analyzed

165 participants

168 participants

-0.2
(0.78)

-0.3
(0.67)

Dryness Week 1

Number Analyzed

170 participants

175 participants

0.1
(0.54)

0.6
(0.95)

Dryness Week 2

Number Analyzed

169 participants

175 participants

0.0
(0.50)

0.1
(0.58)

Dryness Week 4

Number Analyzed

169 participants

174 participants

0.0
(0.52)

0.1
(0.49)

Dryness Week 8

Number Analyzed

165 participants

171 participants

0.0
(0.58)

0.1
(0.46)

Dryness Week 12

Number Analyzed

165 participants

168 participants

0.0
(0.45)

0.0
(0.35)

Peeling Week 1

Number Analyzed

170 participants

175 participants

0.1
(0.43)

0.5
(0.88)

Peeling Week 2

Number Analyzed

169 participants

175 participants

0.1
(0.33)

0.2
(0.55)

Peeling Week 4

Number Analyzed

169 participants

174 participants

0.0
(0.34)

0.1
(0.42)

Peeling Week 8

Number Analyzed

165 participants

171 participants

0.1
(0.39)

0.1
(0.46)

Peeling Week 12

Number Analyzed

165 participants

168 participants

0.0
(0.31)

0.0
(0.32)

Itching Week 1

Number Analyzed

170 participants

175 participants

0.0
(0.64)

0.1
(0.81)

Itching Week 2

Number Analyzed

169 participants

175 participants

0.0
(0.60)

0.1
(0.77)

Itching Week 4

Number Analyzed

169 participants

174 participants

-0.1
(0.68)

-0.1
(0.62)

Itching Week 8

Number Analyzed

165 participants

171 participants

-0.2
(0.63)

-0.1
(0.58)

Itching Week 12

Number Analyzed

165 participants

168 participants

-0.2
(0.66)

-0.2
(0.56)

Burning/Stinging Week 1

Number Analyzed

170 participants

175 participants

0.0
(0.48)

0.5
(0.85)

Burning/Stinging Week 2

Number Analyzed

169 participants

175 participants

0.0
(0.44)

0.2
(0.66)

Burning/Stinging Week 4

Number Analyzed

169 participants

174 participants

0.0
(0.44)

0.0
(0.47)

Burning/Stinging Week 8

Number Analyzed

165 participants

171 participants

0.0
(0.34)

0.1
(0.53)

Burning/Stinging Week 12

Number Analyzed

165 participants

168 participants

0.0
(0.39)

0.0
(0.40)

14.Secondary Outcome

Title

Number of Participants With Severity of AEs

Description

The severity of AEs was assessed by the investigator; events were assi...

Description

The severity of AEs was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.

Time Frame

Up to Week 12

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

ITT population.

Arm/Group Title

DUAC

ADA 0.1% +CLDM 1%

Arm/Group Description:

Participants were instructed to use...

Participants were instructed to use...

Arm/Group Description:

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.

Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.

Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.

All-Cause Mortality

Duac

ADA 0.1% +CLDM 1%

Affected / at Risk (%)

Affected / at Risk (%)

Total

--/--

--/--

Serious Adverse Events Serious Adverse Events

Duac

ADA 0.1% +CLDM 1%

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

1/172 (0.58%)

0/177 (0.00%)

Gastrointestinal disorders

Duodenal ulcer † 1

1/172 (0.58%)

0/177 (0.00%)

†

Indicates events were collected by systematic assessment

1

Term from vocabulary, MedDRA

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.